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Displaying 1 - 15 of 278 items.

Health alert or recall Red Woody & Go-Rilla - Undeclared prescription drug sildenafil.
All lots contain an undeclared ingredient (sildenafil) that is listed on the prescription drug list.
RecallHealth product recall | 2022-06-01
Health alert or recall Straight Rod - TI
On 03/17/2022, a Stryker spine operator packaging non-sterile Yukon Straight Rods from finished goods inventory discovered a Yukon Straight Rod 120 mm (cat#7601-540120, lot# pcmw) with orange and white discoloration on the surface of the device.…
RecallHealth product recall | 2022-05-23
Health alert or recall Nim™ Standard Reinforced Emg Endotracheal Tube & Nim Contact™ Reinforced Emg Endotracheal Tube
Manufacturer has received reports of events related to airway obstruction while using the impacted device. Not following the instructions for use (IFU) and over-inflating the cuff increases intra-cuff pressure, which can cause the silicone cuff to extend…
RecallHealth product recall | 2022-05-10
Health alert or recall Breathing System Filter Safestar 55
Dräger has become aware of one case in which an obstructed Breathing System Filter Safestar 55 was used on a patient during anesthesia. The patient reportedly became hypoxic and had to be reanimated. If an obstructed filter is used on a patient,…
RecallHealth product recall | 2022-05-10
Health alert or recall Dragonfly Opstar Imaging Catheter
The proximal marker on devices from these lots may separate from the device. A dislodged marker may require additional intervention, including unplanned additional coronary intervention, or surgery. To date Abbott has received 5 complaints related to…
RecallHealth product recall | 2022-04-25
Health alert or recall Cortrak*2 Enteral Access System (Eas)
Avanos medical is conducting a voluntary field correction for the Cortrak* 2 Enteral Access System (Eas) because modifications to the labeling of the device have been initiated. Reports of injuries and patient deaths related to misplacement of…
RecallHealth product recall | 2022-04-19
Health alert or recall Fabian HFOi Ventilator
Bias flow selection for NO system usage is missing from the user interface of Fabian HFOi Ventilators following incorrect selection of device configuration during a software update. This is caused by human error and there is no defect in the device or…
RecallHealth product recall | 2022-04-12
Health alert or recall Optima Mr430s 1.5t - Main Unit
Potential for injury if the MR system is incorrectly deinstalled. Recall start date: Mar 10, 2022
RecallHealth product recall | 2022-03-21
Health alert or recall Optima Mr360
Potential for injury if the Mr system is incorrectly deinstalled. Recall start date: Mar 10, 2022
RecallHealth product recall | 2022-03-21
Health alert or recall Optima Mr450w
Potential for injury if the MR system is incorrectly deinstalled. Recall start date: Mar 10, 2022
RecallHealth product recall | 2022-03-21
Health alert or recall Med-Rx Medication/Primary Solution Administration Kit
BBMI has identified through complaints the potential for fluid leakage or low fill volume of the respective containers of 0.9% sodium chloride injection USP 250ml [din : 01924303, lot no : l8002]. There is also the potential for smaller micro-leaks which…
RecallHealth product recall | 2022-03-14
Health alert or recall Infinity Centralstation Wide
The recall is being initiated due to a software defect that is triggered by disconnecting / connecting an USB device, causing a restart of the infinity central station and a temporary loss of central monitoring. Recall start date: Mar 8, 2022
RecallHealth product recall | 2022-03-14
Health alert or recall Heparin Sodium and 0.9% Sodium Chloride Injection: leak in intravenous bag
Intravenous bag may be leaking in affected lot
RecallHealth product recall | 2022-03-07
Health alert or recall 0.9% Sodium Chloride Injection USP: Leaking solution bag
 Solution bags may be leaking in affected lot.
RecallHealth product recall | 2022-02-28
Health alert or recall Liquiband Fix8 Open Hernia Mesh Fixation Device
During verification testing, a non-conformance was detected. Failure mode was uncontrolled leakage of glue from the distal tip of the Fix8 open (FX002) device. Recall start date: Feb 3, 2022
RecallHealth product recall | 2022-02-14
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